POWERFLEX 4400504SRecalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 20705032059326), received between Apr 10, 2018 and Apr 17, 2025 — classified as 20 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (16 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 17, 2025Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE BALLOON OF A 5MM X 4CM POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER RUPTURED AT 6 ATMOSPHERES (ATM). AN UNKNOWN DEVICE WAS USED AS A REPLACEMENT WITHOUT ISSUE. THERE WERE NO REPORTED INJURIES TO THE PATIENT. THIS WAS DURING A PROCEDURE TO TREAT A SUPERFICIAL FEMORAL ARTERY (SFA) LESION. A NON-CORDIS GUIDEWIRE WAS USED DURING THE PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT PROVIDED. THE DEVICE WAS NOT RETURNED AS EXPECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21854267 ↗
• MalfunctionJan 16, 2024Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE BALLOON OF A 5MM X 4CM POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER RUPTURED BEFORE REACHING ITS RATED BURST PRESSURE. THE DEVICE WAS REPLACED WITH A NEW 5MM X 4CM POWERFLEX PRO PTA BALLOON CATHETER TO COMPETE THE PROCEDURE. THERE WERE NO REPORTED INJURIES TO THE PATIENT. THIS WAS DURING A PROCEDURE TO TREAT A 90% STENOSED ILIAC LESION WHICH HAD MILD CALCIFICATION AND MILD TORTUOSITY. THE DEVICE WAS STORED, HANDLED, AND PREPPED PER THE INSTRUCTIONS FOR USE (IFU) AND THERE WAS NO DIFFICULTY REMOVING ANY OF THE STERILE PACKAGING COMPONENTS. THE DEVICE WAS ABLE TO MAINTAIN NEGATIVE PRESSURE DURING PREPARATION. THE INITIAL POWERFLEX PRO PTA BALLOON CATHETER WAS INFLATED AND DEFLATED SEVERAL TIMES PRIOR TO THE BALLOON RUPTURE. THE DEVICE WAS ABLE TO BE REMOVED EASILY FROM THE PATIENT AND REMAIN IN ONE PIECE DURING ITS REMOVAL. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18519991 ↗
• MalfunctionJan 12, 2024Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE 5MM 4CM POWERFLEX PRO WAS USED TOGETHER WITH A NON-CORDIS GUIDEWIRE BUT RUPTURED BEFORE THE PRESSURE REACHES ITS NOMINAL PRESSURE. THERE WAS NO REPORTED INJURY TO THE PATIENT. THIS WAS A PTA CASE. THE LESION WAS THE POPLITEAL ARTERY. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION. ADDITIONAL INFORMATION WAS REQUESTED; HOWEVER, THE INFORMATION COULD NOT BE OBTAINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18503462 ↗
• MalfunctionAug 28, 2023Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  AS REPORTED, THE FACILITY RECEIVED 10 POWERFLEX PRO BALLOONS (MULTIPLE SIZES) THAT WERE CONTAMINATED WITH DIRT PARTICLES EITHER IN BOX AND OR PACKAGING. FOR FEAR OF CONTAMINATING STERILE FIELD, TWO OF THESE BALLOONS THAT WERE GOING TO BE USED DID NOT GET OPENED BECAUSE PROCEDURAL PERSON NOTICED THE DIRT PRIOR TO OPENING. UPON FURTHER INSPECTION OF REMAINING BALLOONS, THEY DISCOVERED THAT AN ADDITIONAL 8 BALLOONS WERE SIMILARLY CONTAMINATED. THERE WAS NO REPORTED INJURY TO THE PATIENT. IT IS UNKNOWN IF THE DIRT PARTICLES WERE WITHIN THE SEALED PORTION OF THE PACKAGES. THE FACILITY DOES NOT HAVE A RECEIVING BAY. THE DEVICES WERE STORED FOR APPROXIMATELY ONE MONTH PRIOR TO USE. THERE WERE NO DAMAGES NOTED TO THE SHIPPING BOXES. THERE WAS NO DAMAGE NOTED TO THE ACTUAL DEVICE PACKAGING. THE DEVICES WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17639056 ↗
• MalfunctionAug 28, 2023Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  AS REPORTED, THE FACILITY RECEIVED 10 POWERFLEX PRO BALLOONS (MULTIPLE SIZES) THAT WERE CONTAMINATED WITH DIRT PARTICLES EITHER IN BOX AND OR PACKAGING. FOR FEAR OF CONTAMINATING STERILE FIELD, TWO OF THESE BALLOONS THAT WERE GOING TO BE USED DID NOT GET OPENED BECAUSE PROCEDURAL PERSON NOTICED THE DIRT PRIOR TO OPENING. UPON FURTHER INSPECTION OF REMAINING BALLOONS, THEY DISCOVERED THAT AN ADDITIONAL 8 BALLOONS WERE SIMILARLY CONTAMINATED. THERE WAS NO REPORTED INJURY TO THE PATIENT. IT IS UNKNOWN IF THE DIRT PARTICLES WERE WITHIN THE SEALED PORTION OF THE PACKAGES. THE FACILITY DOES NOT HAVE A RECEIVING BAY. THE DEVICES WERE STORED FOR APPROXIMATELY ONE MONTH PRIOR TO USE. THERE WERE NO DAMAGES NOTED TO THE SHIPPING BOXES. THERE WAS NO DAMAGE NOTED TO THE ACTUAL DEVICE PACKAGING. THE DEVICES WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17639052 ↗
• MalfunctionAug 28, 2023Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  AS REPORTED, THE FACILITY RECEIVED 10 POWERFLEX PRO BALLOONS (MULTIPLE SIZES) THAT WERE CONTAMINATED WITH DIRT PARTICLES EITHER IN BOX AND OR PACKAGING. FOR FEAR OF CONTAMINATING STERILE FIELD, TWO OF THESE BALLOONS THAT WERE GOING TO BE USED DID NOT GET OPENED BECAUSE PROCEDURAL PERSON NOTICED THE DIRT PRIOR TO OPENING. UPON FURTHER INSPECTION OF REMAINING BALLOONS, THEY DISCOVERED THAT AN ADDITIONAL 8 BALLOONS WERE SIMILARLY CONTAMINATED. THERE WAS NO REPORTED INJURY TO THE PATIENT. IT IS UNKNOWN IF THE DIRT PARTICLES WERE WITHIN THE SEALED PORTION OF THE PACKAGES. THE FACILITY DOES NOT HAVE A RECEIVING BAY. THE DEVICES WERE STORED FOR APPROXIMATELY ONE MONTH PRIOR TO USE. THERE WERE NO DAMAGES NOTED TO THE SHIPPING BOXES. THERE WAS NO DAMAGE NOTED TO THE ACTUAL DEVICE PACKAGING. THE DEVICES WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17639028 ↗
• MalfunctionSep 23, 2022Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, DURING THE INITIAL INFLATION OF A 5MM X 4CM 80CM POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER, THE MID-PORTION OF THE BALLOON DID NOT FULLY EXPAND WHEN THE DEVICE WAS INFLATED TO ITS NOMINAL PRESSURE. THEREFORE, THE DEVICE WAS DEFLATED WITHOUT ISSUE, AND SEVERAL INFLATIONS WERE MADE IN AN ATTEMPT TO FULLY EXPAND THE BALLOON. THE BALLOON WAS ABLE TO BE FULLY EXPANDED DURING AN INFLATION TO 12 ATMOSPHERES (ATM); HOWEVER, THE BALLOON RUPTURED DURING THIS INFLATION. THE PROCEDURE WAS ENDED AFTER THE USE OF THE POWERFLEX PRO PTA BALLOON CATHETER AND THERE WAS NO REPORTED INJURY TO THE PATIENT. THIS WAS DURING A VASCULAR ACCESS INTERVENTIONAL THERAPY (VAIVT) PROCEDURE TO TREAT A 99% STENOSIS JUST ABOVE AN ANASTOMOTIC SITE. THE LESION HAD SEVERE VESSEL TORTUOSITY AND MILD CALCIFICATION BUT WAS NOT A CHRONIC TOTAL OCCLUSION (CTO). A NON-CORDIS .035 GUIDEWIRE WAS USED FOR THIS PROCEDURE AND THERE WERE NO ISSUES WITH THIS GUIDEWIRE. THE DEVICE WAS STORED AND PREPPED PER THE INSTRUCTIONS FOR USE (IFU) AND MAINTAINED NEGATIVE PRESSURE DURING PREPARATION. A 50/50 CONTRAST AND SALINE MIXTURE WAS USED TO PREP THE BALLOON. THERE WAS NO DIFFICULTY REMOVING

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15472174 ↗
• MalfunctionAug 2, 2022Material Rupture

  AS REPORTED, THE BALLOON OF A 5MM X 4CM 80CM POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER RUPTURED DURING AN INFLATION WITHIN NOMINAL PRESSURE. AS A RESULT, AN UNKNOWN DEVICE OF THE SAME SIZE WAS USED IN PACE OF THE 5MM X 4CM 80CM POWERFLEX PRO BALLOON CATHETER. THIS WAS FOLLOWED BY THE IMPLANTATION OF AN UNKNOWN STENT TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED INJURY TO THE PATIENT. THIS WAS DURING AN INTENTIONAL PROCEDURE TO TREAT AN ILIAC ARTERY LESION IN WHICH AN UNKNOWN GUIDEWIRE WAS USED AND WAS ABLE TO SUCCESSFULLY CROSS THE TARGET LESION. THE DEVICE WAS DISCARDED AND WILL NOT BE RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15145624 ↗
• MalfunctionJul 1, 2022Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE BALLOON OF A 5MM X 4CM 80CM POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER RUPTURED WITHIN ITS NOMINAL PRESSURE AT 4 ATMOSPHERES (ATM). AS A RESULT, THE 5MM X 4CM 80CM POWERFLEX PRO PTA BALLOON CATHETER WAS REPLACED WITH AN UNKNOWN 5MM X 4CM BALLOON CATHETER WHICH WAS USED WITHOUT ISSUE. THIS WAS FOLLOWED BY THE IMPLANTATION OF AN UNKNOWN STENT TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED INJURY TO THE PATIENT. THIS WAS DURING AN INTERVENTIONAL PROCEDURE TO TREAT A LESION IN THE ILIAC ARTERY IN WHICH AN IPSILATERAL RETROGRADE APPROACH WAS USED. A NON-CORDIS GUIDEWIRE WAS USED DURING THIS PROCEDURE AND WAS ABLE TO CROSS THE LESION. ADDITIONAL INFORMATION AS REQUESTED BUT WAS NOT PROVIDED. THE DEVICE HAS NOW BEEN RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14888180 ↗
• MalfunctionMay 25, 2021Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE 5MM X 4CM X 80CM POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER (BC) CROSSED THE LESION AND INFLATED TO 10 ATMOSPHERIC PRESSURE (ATM); HOWEVER, IT RUPTURED AT 10 ATM. USING A NON-CORDIS BALLOON CATHETER, THE USER EXPANDED THE SMART STENT TO FINISH THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WAS OPENED IN STERILE FIELD. THE LESION WAS THE COMMON ILIAC ARTERY. THE POWERFLEX PRO WAS USED AT THE LEFT EXTERNAL ILIAC ARTERY. THE OPERATOR WAS A TRAINED POWERFLEX PRO USER. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS AS IT WAS DISCARDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11876189 ↗
• MalfunctionApr 13, 2021Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, A 5MM X 4CM X 80CM POWER FLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER WAS USED BUT IT RUPTURED AT 4 ATMOSPHERES (ATM). THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION DUE TO INFECTIOUS DISEASE. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11654510 ↗
• MalfunctionNov 25, 2020Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, A 5MM X 4CM X 80CM POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER WAS USED FOR PLAIN OLD-BALLOON ANGIOPLASTY (POBA); HOWEVER, RUPTURED WITHIN ITS NOMINAL PRESSURE. AFTER THAT, SMART STENT WAS USED AND POST DILATION WAS PERFORMED WITH A 6MM UNKNOWN BALLOON CATHETER, AND THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORTED PATIENT INJURY. THIS WAS AN ENDOVASCULAR THERAPY (EVT) CASE. THE TARGET LESION WAS THE ILIAC ARTERY WHICH HAD CHRONIC TOTAL OCCLUSION (CTO). AN IPSILATERAL APPROACH WAS MADE WITH A 4F UNKNOWN SHEATH AND A CONTRALATERAL APPROACH WAS MADE WITH A 6F UNKNOWN SHEATH. A NON-CORDIS GUIDEWIRE WAS INSERTED FROM IPSILATERAL AND CROSSED THE CTO. THE TWO SABER RAPID EXCHANGE (RX) (3MM AND 4MM) PTA BALLOONS PERFORMED PRE-DILATION. AFTER THAT, THE GUIDEWIRE WAS CHANGED TO ANOTHER 35¿ NON-CORDIS GUIDEWIRE. THE PATIENT HAD NO INFECTIOUS DISEASE. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION AS IT WAS DISCARDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10899945 ↗
• MalfunctionSep 28, 2020Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE BALLOON OF A 5MM X 4CM X 80 POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER RUPTURED DURING INITIAL INFLATION WHEN IT WAS INSERTED AND ATTEMPTED TO BE INFLATED AT ITS NOMINAL PRESSURE. THEREFORE, IT WAS REPLACED WITH A NEW NON-CORDIS BALLOON CATHETER AND THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORTED PATIENT INJURY. THE LESION WAS THE RIGHT SUPERFICIAL FEMORAL ARTERY WHICH HAD 70% STENOSIS AND SEVERE CALCIFICATION. AN IPSILATERAL APPROACH WAS MADE. AN UNKNOWN WIRE (35) CROSSED THE LESION. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION BECAUSE IT WAS DISCARDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10596152 ↗
• MalfunctionJun 11, 2020Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE 5MM X 4CM X 80CM POWERFLEX PRO WAS USED, HOWEVER, IT RUPTURED AT 8 ATMOSPHERIC PRESSURE (ATM). THEREFORE, IT WAS REPLACED WITH A NEW UNKNOWN BALLOON CATHETER AND PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) WAS PERFORMED. THERE WAS NO REPORTED PATIENT INJURY. THE LESION WAS THE SUPERFICIAL FEMORAL ARTERY. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS AS IT WAS DISCARDED DUE TO INFECTIOUS DISEASE. ADDITIONAL PROCEDURAL DETAILS WERE REQUESTED BUT ARE UNKNOWN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10144522 ↗
• MalfunctionMay 8, 2020Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, A 5MM X 4CM 80CM POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER WAS INFLATED HOWEVER, IT RUPTURED AT 10 ATMOSPHERES(ATM) DURING ITS INITIAL INFLATION. THEREFORE, IT WAS REPLACED WITH A NEW 6MM X 4CM NON-CORDIS BALLOON CATHETER AND THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORTED PATIENT INJURY. THE TARGET LESION WAS THE RIGHT COMMON FEMORAL ARTERY. THE LESION HAD HEAVY STENOSIS AND SEEMED TO BE HEAVILY CALCIFIED. A CONTRALATERAL APPROACH WAS MADE WITH A 6F NON-CORDIS GUIDING SHEATH AND A NON-CORDIS GUIDEWIRE WHICH CROSSED THE LESION. THE PHYSICIAN CONFIRMED THE LESION WITH AN INTRAVASCULAR ULTRASOUND (IVUS). THE DEVICE WILL NOT BE RETURNED AS IT WAS DISCARDED IN THE HOSPITAL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10039566 ↗
• MalfunctionSep 26, 2019Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, A 5MMX4CM 80 POWERFLEX PRO WAS INSERTED FOR PRE-DILATION, HOWEVER, IT RUPTURED AT 4 ATMOSPHERE (ATM). IT WAS WITHIN ITS NOMINAL PRESSURE. THERE WAS NO PATIENT INJURY. THE DEVICE WAS REPLACED WITH A SAME SIZE NEW NON-CORDIS BALLOON CATHETER AND THE PROCEDURE WAS COMPLETED. THIS WAS A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CASE. THE LESION WAS THE RIGHT COMMON ILIAC ARTERY. THE DEVICE WAS DISCARDED BECAUSE THE PATIENT HAD (B)(6).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9123711 ↗
• MalfunctionAug 30, 2019Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, A POWERFLEX PRO 5MM4CM 80 WAS USED FOR PRE-DILATION; HOWEVER, IT RUPTURED. THERE WERE NO REPORTED PATIENT INJURIES. THE DEVICE WAS REPLACED WITH A SAME SIZED NON-CORDIS NEW BALLOON CATHETER AND THE PROCEDURE WAS COMPLETED. THE TARGET LESION WAS THE ILIAC ARTERY. THE DEVICE WAS DISCARDED DUE TO SUSPICIOUS INFECTIOUS DISEASE. THE DEVICE WAS STORED ON THE SHELF IN THE CATH LAB. THE DEVICE WAS STORED IN THE CATH LAB FOR ONE MONTH. THE DEVICE WAS STORED, HANDLED AND PREPPED PER THE INSTRUCTIONS FOR USE (IFU). THE DEVICE WAS PREPPED NORMALLY BY MAINTAINING NEGATIVE PRESSURE. THERE WAS NO DIFFICULTY REMOVING THE PRODUCT FROM THE HOOP OR REMOVING THE PROTECTIVE BALLOON COVER. THERE WAS NO DIFFICULTY REMOVING THE STYLET OR ANY OF THE STERILE PACKAGING COMPONENTS. THE SAME INDEFLATOR WAS USED SUCCESSFULLY WITH OTHER DEVICES. THERE WERE NO KINKS OR OTHER DAMAGES NOTED PRIOR TO INSERTING THE PRODUCT INTO THE PATIENT. THE BALLOON CATHETER WAS REMOVED EASILY AND INTACT. THE LESION WAS MODERATELY CALCIFIED, WITH LITTLE VESSEL TORTUOSITY

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8952474 ↗
• MalfunctionAug 6, 2019Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, A POWERFLEX PRO PTA BALLOON CATHETER (5MM4CM 80) WAS INSERTED FOR INFLATION. HOWEVER, IT RUPTURED AT ITS NOMINAL PRESSURE. THERE WAS NO REPORTED PATIENT INJURY. THEREFORE, THE POWERFLEX PTA BALLOON WAS REPLACED WITH A NON-CORDIS BALLOON CATHETER (5*40) AND INFLATED. THE PROCEDURE WAS COMPLETED. INITIALLY, THIS WAS A SHUNT ANASTOMOSIS PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CASE. THE VESSEL LEVEL OF CALCIFICATION IS SEVERE. THE VESSEL LEVEL OF ANGULATION AND TORTUOSITY IS MODERATE. THE DEVICE WAS PREPPED PER THE INSTRUCTIONS FOR USE (IFU). THE DEVICE WAS PREP NORMALLY. THE CONTRAST TO SALINE RATIO WAS 50:50. THE SAME INDEFLATOR WAS USED SUCCESSFULLY WITH OTHER DEVICES. THERE WERE NO KINK/BENT NOTED AFTER DEVICE WAS REMOVED FROM PATIENT. THE DEVICE WAS REMOVED INTACT (IN ONE PIECE) FROM THE PATIENT. THERE IS NO PROCEDURAL FILM/CD AVAILABLE FOR REVIEW. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS AS THE DEVICE WAS DISCARDED IN THE HOSPITAL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8864185 ↗
• MalfunctionJun 28, 2019Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, A NON-CORDIS GUIDEWIRE CROSSED THE LESION AND A POWERFLEX PRO 5MM4CM 80 WAS INSERTED, HOWEVER, IT COULD NOT CROSS THE LESION, THE DOCTOR ATTEMPTED SEVERAL TIMES BY PUSHING IT, BUT IT STILL DID NOT CROSS. THE POWERFLEX PRO WAS CONNECTED WITH AN INFLATION DEVICE FOR PRE INFLATION, WHEN IT WAS DEFLATED, BACK-FLOW WAS CONFIRMED. THE POWERFLEX PRO BALLOON RUPTURED BEFORE THE INFLATION. THERE WERE NO REPORTED PATIENT INJURIES. THE BALLOON WAS REPLACED WITH A SAME SIZE SABER BALLOON CATHETER. IT COULD CROSS THE LESION AND BE INFLATED. A SMART STENT WAS THEN IMPLANTED, AND THE PROCEDURE WAS COMPLETED. THE LESION WAS THE COMMON ILIAC ARTERY AND THE EXTERNAL ILIAC ARTERY. AN IPSILATERAL RETROGRADE WAS MADE. THE VESSEL WAS HEAVILY CALCIFIED AND MODERATELY TORTUOUS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8744813 ↗
• MalfunctionApr 10, 2018Burst Container or Vessel; Burst Container or Vessel

  DURING USE, IT WAS REPORTED THAT THE POWER FLEX PRO RUPTURED AT THREE ATMOSPHERE (3ATM). THERE WAS NO PATIENT INJURY. THE LESION WAS THE EXTERNAL ILIAC ARTERY. AFTER A GUIDEWIRE CROSSED THE LESION, PRE DILATATION WAS MADE AND AN IVUS CHECKED THE LESION. A POWER FLEX PRO WAS INFLATED IN THE LESION, BUT IT WAS RUPTURED AT 3ATM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7412309 ↗